Using Shenfu Injection to Protect Heart Function in Septic Shock
The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis: a Multicenter, Randomized Controlled Study
This study tests if adding Shenfu Injection to regular treatment can help people with septic shock keep their hearts working better and recover faster.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital of Wannan Medical College Academic / other |
| Locations | 1 site (Wuhu, Anhui) |
| Trial ID | NCT06898723 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Shenfu Injection, a traditional Chinese medicine, in preventing heart dysfunction in patients experiencing septic shock. The study aims to determine if adding this injection to standard treatment can enhance cardiac function, accelerate recovery, and improve survival rates. It is a multicenter, randomized controlled trial comparing outcomes between patients receiving standard care alone and those receiving standard care plus Shenfu Injection. The trial focuses on patients diagnosed with septic shock according to Sepsis 3.0 criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with septic shock.
Not a fit: Patients with severe underlying diseases or recent severe cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart function and survival rates in patients suffering from septic shock.
How similar studies have performed: While traditional Chinese medicine approaches have been explored, the specific use of Shenfu Injection in this context is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Patients clinically diagnosed with septic shock must meet the diagnostic criteria of Sepsis 3.0; * 2\. Age ≥ 18 years. Exclusion Criteria: * 1\. Pregnant or breastfeeding women; * 2\. Individuals with a history of allergies or known hypersensitivity to Ginseng and Aconite Injection or its components; * 3\. Severe underlying diseases that may affect prognosis, including uncontrolled malignant tumors with multiple metastases that are unresectable, hematological disorders, cachexia, persistent active bleeding, severe malnutrition, HIV, etc.; * 4\. Severe cardiac conditions within the last three months, including acute unstable myocardial infarction, dilated cardiomyopathy, acute coronary syndrome, acute or chronic valvular heart disease, and congestive heart failure (New York Heart Association \[NYHA\] Class IV); * 5\. Any of the following medical procedures performed within the last three months: any form of cardiac surgery, thoracotomy, external cardiac compression, defibrillation, direct current cardioversion, or trauma; * 6\. Use of Ginseng and Aconite Injection for less than 48 hours; * 7\. Patients expected to die within 48 hours; * 8\. Patients deemed unsuitable for this study by the investigator.
Where this trial is running
Wuhu, Anhui
- The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College) — Wuhu, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Qiancheng Xu
- Email: qianchengxu@wnmc.edu.cn
- Phone: 86-18297529106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.